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The reported event was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be air leaks in the fluid delivery line.However, this could not be confirmed.It was undetermined what caused this issue although potentially the pads may have been pinched or not attached correctly causing a temporary flow issue although this cannot be confirmed.No physical repairs were made and the unit was not physically evaluated.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1.1 introduction the effect of temperature variations on the human body has been well documented.Elevated temperatures may be harmful to the brain under normal conditions, and even more importantly, during periods of physical stress, such as illness or surgery.Conversely, lower body temperatures, or mild hypothermia, may offer some degree of neuroprotection.Moderate to profound hypothermia (below 32ºc) tends to be more harmful to the body and may lead to death.Temperature management or thermoregulation can be viewed in two different ways.The first aspect of temperature management includes treating abnormal body temperatures, i.E.Cooling the body from elevated temperatures (hyperthermia), or warming the body to manage hypothermia.The second aspect of thermoregulation is an evolving treatment that employs techniques that physically control a patient¿s temperature to provide a physiological benefit, such as cooling for a degree of neuroprotection hypothermia may occur for a variety of reasons, including exposure to cold environments, trauma, or long complex surgical procedures.Hyperthermia may occur as a result of systemic inflammatory response, sepsis, stroke, or other brain injury.While the mechanism of the effect of the hyperthermia on the brain is not clearly understood, there is evidence to indicate that even mild increases in temperature may contribute to neurological deficits.The medivance arctic sun temperature management system has been designed to regulate body temperature for those patients who require procedures requiring therapeutic temperature management and/or to assist in controlling temperature for specific medical or surgical conditions.Caution: this product is to be used by or under the supervision of trained, qualified medical personnel.1.3 environmental conditions the arctic sun model 2000 should be stored and used in specific operating conditions: operating temperature range: 10ºc to 27ºc (50ºf to 80ºf) storage temperature range: -30ºc to 50ºc (-20ºf to 120ºf) at operating temperatures higher than 27ºc (80ºf), the refrigeration system¿s cooling capacity and therefore its ability to cool a patient is compromised.If the control module is to be exposed to subfreezing temperatures, refer to the service manual for special draining procedures.Ambient humidity range: operating: 5% to 70% relative humidity, non-condensing storage: 5% to 95% relative humidity, non-condensing 1.4 indications for use the arctic sun temperature management system is intended for monitoring and controlling patient temperature within a range of 32°c to 38.5°c (89.6ºf to 101.3ºf).The indications for use include any condition where patient temperature control within a range covering mild hypothermia to normothermia is required.This would include, but not limited to, medical, surgical, febrile, accidental hypothermia, or heat stroke patients.Caution: federal law (usa) restricts this device to sale by or on the order of a physician.1.5 contraindications for use there are no known contraindications for the use of a thermoregulatory system.Do not place arcticgel pads¿ on skin that has signs of ulceration, burns, hives, or rash.While there are no known allergies to hydrogel materials, caution should be exercised with any patient who has a history of skin allergies or sensitivities.1.6 warnings ¿ do not use the arctic sun in the presence of flammable agents because an explosion and/or fire may result.¿ there is a risk of electrical shock and hazardous moving parts.There are no user serviceable parts inside.Do not remove covers.Refer servicing to qualified personnel.¿ power cord has a hospital grade plug.Grounding reliability can only be achieved when connected to an equivalent receptacle marked ¿hospital use¿ or ¿hospital grade¿.¿ when using the arctic sun, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the arctic sun may actually alter or interfere with patient temperature control.1.7 cautions ¿ this product is to be used by or under the supervision of trained, qualified medical personnel.¿ federal law (usa) restricts this device to sale, by or on the order of a physician.¿ use only distilled or sterile water.The use of other fluids will damage the arctic sun model 2000.¿ the patient¿s bed surface should be located between 30 and 60 inches (75 cm and 150 cm) above the floor to ensure proper flow and minimize risk of leaks.¿ the operator is responsible to determine the appropriateness of custom parameters.¿ when the system is powered off, all changes to parameters will revert to the default unless the new settings have been saved as new defaults.¿ the operator must continuously monitor patient temperature in manual mode.Patient temperature will not be controlled by the arctic sun in manual mode.¿ the arctic sun will monitor and control patient core temperature based on the temperature probe attached to the system.Medivance recommends measuring patient temperature from a second site to verify patient temperature.¿ it is the sole responsibility of the clinician or operator to monitor patient temperature during manual mode and to adjust the temperature of the water flowing through the pads accordingly.¿ due to the system¿s high efficiency, manual mode is not recommended for non-surgical treatments that require cooling.¿ patient temperature will not be controlled and alarms are not enabled in stop mode.Patient temperature may increase or decrease with the arctic sun in stop mode.¿ it is advisable not to cancel the alarm or alert until the situation is resolved.If an alarm is canceled and the condition has not been corrected, the alarm will recur.If an alert is canceled and the alert condition has not been corrected, the alert will not recur unless the stop mode is activated.¿ carefully observe the system for air leaks in the system before and during use.If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections.If needed, replace the leaking pad.Leakage may result in lower flow rates and potentially decrease the performance of the system.¿ the arctic sun model 2000 is for use only with the arcticgel pads.¿ the arcticgel pads are only for use with an arctic sun model 2000.¿ the arcticgel pads are non-sterile for single patient use.Do not reprocess or sterilize.If used in a sterile environment, pads should be placed according to the physician¿s request, either prior to the sterile preparation or sterile draping.Arcticgel pads should not be placed on a sterile field.¿ use pads immediately after opening.Do not store pads once the kit has been opened.¿ do not allow circulating water to contaminate the sterile field when patient lines are disconnected.¿ the water content of the hydrogel affects the pad¿s adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature.Periodically check that pads remain moist and adherent.Replace pads when the hydrogel no longer uniformly adheres to the skin.Replacing pads at least every 5 days is recommended.¿ do not puncture the arcticgel pads with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ if accessible, examine the patient¿s skin under the arcticgel pads often, especially those at higher risk of skin injury.¿ skin injury may occur as a cumulative result of pressure, time and temperature.Do not place bean bag or other firm positioning devices under the arcticgel pads.Do not place positioning devices under the pad manifolds or patient lines.¿ the rate of temperature change and potentially the final achievable patient temperature is affected by many factors.Treatment application, monitoring and results are the responsibility of the attending physician.If the patient does not reach target temperature in a reasonable time or the patient is not able to be maintained at the target temperature, the skin may be exposed to low water temperatures for an extended period of time which may increase the risk for skin injury.Ensure that pad sizing / coverage and custom parameter settings are correct for the patient and treatment goals, environmental factors such as excessively hot rooms, heat lamps, and heated nebulizers are eliminated, water flow is greater than or equal to 2.3 liters per minute, a patient temperature probe is in the correct place, and patient shivering is controlled.Otherwise, consider increasing minimum water temperature, modifying target temperature to an attainable setting, or discontinuing treatment.¿ due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold.Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status, steroid use or high dose vasopressor therapy.If warranted, use pressure relieving or pressure reducing devices under the patient to protect from of skin injury.¿ do not allow antibacterial agents to pool underneath the arcticgel pads.Excess antibacterial agents can absorb into the pad adhesive and cause chemical burns and loss of pad adhesion.¿ do not place arcticgel pads over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ carefully remove arcticgel pads from the patient¿s skin at the completion of use.¿ any device connected to the rs232 data port must comply with the applicable iec standard for that device.¿ users should not use cleaning or decontamination methods different from those recommended by the manufacturer without first checking with the manufacturer that the proposed methods will not damage the equipment.¿ medivance will not be responsible for patient safety or equipment performance if the procedures to operate, maintain, modify or service the medivance arctic sun are other than those specified by medivance.Anyone performing the procedures must be appropriately trained and qualified." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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